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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lung computed tomography system, computer-aided detection
510(k) Number K193216
Device Name syngo.CT Lung CAD
Applicant
Siemens Medical Solutions, Inc
65 Valley Stream Parkway
Malvern,  PA  19355
Applicant Contact Abhineet Johri
Correspondent
Siemens Medical Solutions, Inc
65 Valley Stream Parkway
Malvern,  PA  19355
Correspondent Contact Abhineet Johri
Regulation Number892.2050
Classification Product Code
OEB  
Date Received11/21/2019
Decision Date 03/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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